MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JETSTREAM XC; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	112264-001
Medical Device Problem Codes	Suction Problem (2170); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter aspiration became blocked on the first and second catheter.This 2.1 mm jetstream xc catheter was selected for atherectomy treatment of long segment disease and instent restenosis in femoral, popliteal and posterior tibial artery.During the procedure, the catheter worked for approximately 250 cc/second of fluid, but then the catheter became blocked upon blades up on 3rd attempt.The device was removed to rex in saline bowl to clear aspiration port, and again attempted with no real suction observed.Another new 2.1 mm jetstream xc catheter was opened and advanced slowly; however, the new catheter only worked another 200 cc/second of fluid before becoming blocked upon the 4th pass.The physician wanted to adhere to instent restenosis further and decided to open one more jetstream catheter, which was able to complete the procedure successfully without sequelae.
Additional Manufacturer Narrative
Device eval by manufacturer: this 2.1 mm jetstream xc catheter was returned and analyzed.The device was connected to the console per the instructions for use, and functional testing was performed with no errors.Aspiration testing of the device was completed, and the test results revealed that this device performed as designed per the test procedure specification sheet.The device was visually and microscopically inspected for damage, which revealed a kink 1 cm from the tip causing the blades to not spin.
Event or Problem Description
It was reported that the catheter aspiration became blocked on the first and second catheter.This 2.1 mm jetstream xc catheter was selected for atherectomy treatment of long segment disease and instent restenosis in femoral, popliteal and posterior tibial artery.During the procedure, the catheter worked for approximately 250 cc/second of fluid, but then the catheter became blocked upon blades up on 3rd attempt.The device was removed to rex in saline bowl to clear aspiration port, and again attempted with no real suction observed.Another new 2.1 mm jetstream xc catheter was opened and advanced slowly; however, the new catheter only worked another 200 cc/second of fluid before becoming blocked upon the 4th pass.The physician wanted to adhere to instent restenosis further and decided to open one more jetstream catheter, which was able to complete the procedure successfully without sequelae.

• Brand Name: JETSTREAM XC
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20560114
• Report Number: 2124215-2024-67833
• Device Sequence Number: 11541839
• Product Code: MCW
• UDI-Device Identifier: 08714729889892
• UDI-Public: 08714729889892
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K133023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/14/2026
• Device Model Number: 112264-001
• Device Catalogue Number: 112264-001
• Device Lot Number: 0033408648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2024
• Supplement Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 014 THRUWAY WIRE.; 014 THRUWAY WIRE.; 2.1 MM JETSTREAM XC CATHETER.; 2.1 MM JETSTREAM XC CATHETER.
• Patient Age: 72 YR
• Patient Sex: Male